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The Reliance Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is either made of PEEK OPTIMA LT1 with Tantalum markers or with PEEK OPTIMA LT1-HA with Tantalum markers.

The provided document is a 510(k) summary for the Reliance Lumbar IBF System, which is an intervertebral body fusion device. This type of regulatory submission usually does not include detailed studies on software performance or AI algorithms, as it primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device based on material, intended use, and mechanical/performance testing for the physical device itself.

Therefore, the information requested about acceptance criteria and studies proving the device meets those criteria, particularly pertaining to AI or software performance, is not present in this document. The document describes non-clinical testing for the physical implant components, specifically Finite Element Analysis to assess the effect of new sizes on structural properties, and sterilization validation.

Here's a breakdown of why the requested information cannot be provided from this document:

1. A table of acceptance criteria and the reported device performance: This document only states that "Finite Element Analysis has been carried out to access the effect of new sizes on the structural properties of the implant. Test results show the new components are not the new worst case when compared to the approved Reliance Lumbar IBF PEEK, 1-04-XXX, per K113540." It does not provide specific acceptance criteria or quantitative performance data from this analysis.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned, as the testing described is primarily mechanical/structural analysis, not software validation on clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this is not a study involving expert-derived ground truth for software or AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a physical medical implant, not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm or AI component described.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for the type of testing described (mechanical testing).

8. The sample size for the training set: Not applicable. No AI training is described.

9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission relates to a physical intervertebral body fusion device and not a software or AI-powered medical device. Therefore, the detailed information about AI-related acceptance criteria, studies, and data provenance is not relevant to this document and is not present.

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The Reliance Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level. Additional supplemental fixation is not necessary for the Lumbar IBF-S if the integrated screws are implanted.

The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System is comprised of lumbar intervertebral body fusion devices and associated surgical instruments. This submission adds a line extension, the Reliance Lumbar IBF-S devices, which consist of spacers made of PEEK Optima LT1 with Tantalum markers, and integrated screws, faceplates, and locking plates manufactured from titanium alloy.

The provided text describes a medical device, the Reliance Lumbar IBF System, and its regulatory clearance process (510(k)). It does not include details about acceptance criteria, device performance metrics, or any clinical studies involving human readers or AI algorithms. The "Performance Data and Substantial Equivalence" section only mentions mechanical testing performed on the device to establish substantial equivalence to predicate devices, focusing on physical properties rather than diagnostic performance.

Therefore, I cannot extract the requested information from the provided text as it is not present. The document focuses on regulatory approval based on substantial equivalence to existing medical devices, not on the diagnostic performance or AI-assisted interpretation of medical images.

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The Reliance Lumbar IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 Spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System, originally cleared by FDA in K113540, is intended to be used as an intervertebral body fusion device. Reliance Lumbar IBF device is a spacer, which inserts between vertebral bodies in the anterior column of the thoracic and lumbar spine. The device is surgically implanted between vertebral bodies from an anterior, lateral, or posterior surgical approach. The Reliance Lumbar IBF device will be manufactured from PEEK. The PEEK device also contains Tantalum wires to aid in fluoroscopic visualization. The construct is not intended to be employed as a standalone device. The Reliance Lumbar IBF is to be used with supplemental fixation in all applications.

The provided text describes a 510(k) premarket notification for the "Reliance Lumbar IBF System" and does not contain information related to an AI/ML powered device, nor does it present acceptance criteria or a study proving device performance as typically expected for such devices.

The document is for an intervertebral body fusion device and outlines its indications for use, technological modifications (additional implant sizes and instruments), and claims substantial equivalence to a predicate device. The conclusion is based on a risk analysis and design verification testing, not on a clinical study evaluating diagnostic or prognostic performance of an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set size, as this information is not present in the provided context.

Ask a specific question about this device

The Reliance LUMBAR IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance LUMBAR IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is made of PEEK OPTIMA LT1 with Tantalum markers.

The provided documents are a 510(k) Pre-market Notification from the FDA regarding the "Reliance Lumbar IBF System." This document primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own performance against specific acceptance criteria.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, particularly regarding AI or algorithm performance, cannot be extracted from this document because:

• The device is a physical medical implant (intervertebral body fusion device), not an AI/software device. This type of device does not have "acceptance criteria" in the sense of performance metrics for an algorithm (e.g., sensitivity, specificity, AUC). Its acceptance is based on meeting mechanical and material specifications, biocompatibility, and substantial equivalence to existing devices.
• The document describes "Non-Clinical Testing" which is Finite Element Analysis (FEA). This is a computational method to analyze the mechanical behavior of the additional components, ensuring they do not create a "new worst-case scenario" compared to the predicate device. It's not a study with a test set, ground truth, experts, or statistical performance metrics.
• There is no mention of an algorithm, AI, human readers, or any form of software performance evaluation.

The document does state:

• Device Name: Reliance Lumbar IBF System
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral body fusion device
• Product Code: MAX
• Predicate Devices: Reliance Lumbar IBF System (K113540) and Globus Patriot TransContinental System (K093242, K102313).
• Intended Use/Indications for Use: Intervertebral body fusion of the spine in skeletally mature patients, with autogenous bone graft, intended for the lumbar spine (L2 to S1) for treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.
• Device Description: Made of PEEK OPTIMA LT1 with Tantalum markers.
• Non-Clinical Testing: Finite Element Analysis (FEA) was performed on additional components using Solidworks software and compared to test results of already approved components per K113540. No new components create a new worst-case scenario.

In summary, none of the requested information regarding algorithm-specific acceptance criteria, study design parameters (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set details can be provided from this document as it pertains to a physical implant and not an AI/software medical device.

Ask a specific question about this device

The Reliance LUMBAR IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The Reliance LUMBAR IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.

The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is made of PEEK Optima LT1 with Tantalum markers.

The provided 510(k) summary (K113540) for the Reliance Lumbar IBF System describes performance criteria related to mechanical testing for substantial equivalence to predicate devices, rather than clinical acceptance criteria for a diagnostic or AI-driven device.

Here's the breakdown based on the information provided:

Acceptance Criteria and Device Performance (Mechanical Testing)

Note: The document explicitly states that "The Reliance Lumbar IBF was found to be substantially equivalent to the predicate devices." This implies that the device met the performance benchmarks or passed the tests as per the predicate device's established performance or the industry standard.

The following information is not applicable or not provided in the given 510(k) summary for K113540, as this device is an intervertebral body fusion system and not a diagnostic or AI-powered device. Therefore, questions related to AI performance, expert ground truth, sample sizes for AI training/testing, or MRMC studies are not relevant to this submission.

2. Sample size used for the test set and the data provenance: Not applicable. The testing described is mechanical, not involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is established by mechanical testing standards, not expert consensus.

4. Adjudication method for the test set: Not applicable. Mechanical testing does not involve adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used: For mechanical testing, the "ground truth" is defined by the specific parameters and failure modes outlined in the ASTM standards (F2077-03, F2267-04, and ASTM Draft F-04.25.02.02).

8. The sample size for the training set: Not applicable. Mechanical testing of a physical device does not use a "training set."

9. How the ground truth for the training set was established: Not applicable. See point 8.

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